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HPA Axis Study in Japanese Adults

This study has been completed.
Sponsor:
Information provided by:
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT01407510
First received: August 1, 2011
Last updated: July 19, 2012
Last verified: February 2011
History of Changes
  Purpose

A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.


Condition Intervention Phase
Atopic Dermatitis
Eczema
 Drug: Mapracorat
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Japanese Adults With Atopic Dermatitis

Resource links provided by NLM:

MedlinePlus related topics: Eczema
U.S. FDA Resources

Further study details as provided by Intendis GmbH:

Primary Outcome Measures:
  • number of subjects with adrenal suppression [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: May 2011
Study Completion Date: April 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Mapracorat
    Application of the investigational product on the affected skin areas
Detailed Description:

Assessment of the adrenal suppression potential, safety, efficacy and pharmacokinetics of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Male or female subject aged >= 20 years
  • Diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria
  • Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline
  • Normal ACTH response before start of treatment

Exclusion Criteria:

  • Pregnancy or lactation
  • Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
  • Concomitant medical or dermatological disorder(s), which could interfere with the investigator's ability to evaluate the subject's response to the investigational product
  • Clinically manifest immunosuppressive disorder or known history of malignant disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407510

Locations
Germany
Intendis GmbH
Berlin, Germany, 10589
Sponsors and Collaborators
Intendis GmbH
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Ulrike Ebert, Study Director, Intendis GmbH
ClinicalTrials.gov Identifier: NCT01407510     History of Changes
Other Study ID Numbers: 1403460
Study First Received: August 1, 2011
Last Updated: July 19, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013